IRB agreement used for multisite studies
IRBs can cede review if needed
Multisite studies are a continuing challenge for IRBs — how do you review these protocols quickly and efficiently while preserving the autonomy of individual IRBs?
In Boston, a group of nine collaborating institutions has developed a solution that addresses both those concerns.
The institutions are all affiliated with the Harvard Catalyst, a clinical and translational science center based at Harvard University. They have been working together for three years under a reciprocal IRB reliance agreement, which allows them to cede review of a multi-site protocol to a single IRB.
The agreement was worked out over the course of a year, by about 100 representatives from all of the institutions, in order to craft a process that could be used with a variety of protocols, says Barbara Bierer, MD, senior vice president for research at the Brigham and Women's Hospital as well as the director of the regulatory knowledge and support program for the Catalyst.
"We had all the major players — the vice presidents for research, the office of general counsel and the IRB chairs — working together on this," Bierer says. "These people sat in a room for a year and really came together to understand the reliance agreement and all of its issues."
Bierer says that prior to this arrangement, when investigators from these institutions worked together on projects, they had to seek either separate reviews from all of the institutions involved or a one-to-one reliance agreement for that specific protocol.
"Often, our investigators were taking one protocol and submitting it to three or four IRBs for review and sometimes re-review," she says.
So when the institutions came together to form the Harvard Catalyst under an NIH Clinical and Translational Science Award, one of the first areas they looked at was streamlining this process.
"We focused on decreasing the administrative burden, increasing inter-institutional collaboration and trying to engage the institutions in a process that would simplify investigator collaboration," Bierer says. "We decided to have a master agreement, so you wouldn't need individual signoffs. And that master agreement would cover all of the eventualities that we could foresee."
The reliance agreement was honored recently by the Health Improvement Institute with its Award for Excellence in Human Subjects Protection – Best Practice.
Voluntary decision
Under the agreement, ceding review to another institution's IRB is entirely voluntary for each study and each participating institution. The decision by an institution to handle review for the group or to cede review is made before the investigator officially makes an IRB submission, based on information that he or she provides to the group about the study. Once that decision is made, however, an institution cannot change its mind and demand a separate review.
"Once they decide to rely, they can't read the review of the IRB, and say, 'Now I don't want to rely anymore,'" Bierer says. "You do have to actually rely on somebody, and if there's an issue, you have the ability to go to the IRB and work with that IRB, but you can't strip the IRB of its autonomy."
An investigator who wishes to use the ceded review system is generally required to use the IRB at the institution where he or she is employed, in an effort to avoid "IRB shopping," Bierer says. However, that IRB may make a decision on its own to cede review to another IRB that has particular expertise with a subject.
"This other IRB may be set up specifically for pediatrics, for example, or prisoner research or international research," she says. "So the IRB will cede to it, even though the PI is at their own institution."
The submission is made through a separate electronic system than the Catalyst members' own IRB systems, using a special ceded review request form. This allows the same information to be sent to all of the participating institutions, and for each institution to track its progress.
"As far as Barbara and I know, the ceded review form is the first common form that all the Harvard IRBs have ever accepted," says Sabune Winkler, JD, director of regulatory affairs operations for the Catalyst. "It is standalone and it's designed that way."
Each institution looks at the information about the study and decides whether to cede review to the IRB handling that study. How that decision gets made, and by whom, can vary from site to site or even from study to study, according to Bierer and Winkler.
Winkler says that when an IRB chooses to review the protocol for the group, the principal investigator submits to that institution, using all of its forms and policies.
Hundreds of multisite protocols have been handled through the ceded review process, Bierer says.
Winkler notes that this process is used for all kinds of protocols, not just simple, minimal-risk studies.
"When we talk to people, they're really surprised that we didn't limit it to minimal-risk studies," she says.
Spreading the word
Other institutions have shown interest in adopting a similar model to the Catalyst's reliance agreement. Bierer and Winkler say they've worked with 20 to 30 institutions, explaining how they developed their agreement and the challenges they've overcome.
"We give them the template, and we do tell them a few things," Bierer says. "One is to get the right people in the room [working out the agreement] and to not expect this to be a slam dunk."
Because the Catalyst group has had several years to work with the agreement, Winkler says it has hammered out a lot of the practical details that other institutions may not have identified yet.
"Whether you want common subject injury language, for example, or whether you want to have the right to have another institution go in and audit you," she says. "We realize when we're talking with other institutions that they had really not gotten that far; they were just looking at a document."
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